We’re experienced, competent and will take a pragmatic approach to ensuring regulatory compliance, subject safety and quality data.

PSNResearch Quality Assurance personnel have a broad range and in-depth experience in quality issues for IT and all GxP areas such as GCP, GDP, GLP, GMP and GVP.

In addition to assuring PSNResearch quality standards, our Quality Assurance (QA) department can provide a full auditing service, plus stand-alone quality assurance services to support companies to develop, implement and update their quality systems and procedures to conform to GxP guidelines and regulations.

Our GMP expertise covers biologics, small molecules and the challenges of Advanced Therapy Medicinal Products (ATMPs).

Quality Management Systems (QMS)

  • Developing a quality management systems, including writing of core quality SOPs
  • Writing/ review/ update of SOPs for GxP activities
  • Gap analysis on SOPs and QA systems
  • QA strategy, planning and creating the setup for drug development

Audits

  • Conduct of investigator site audits and pre-inspections
  • Evaluation of external vendors
  • Conduct of vendor audits
  • Consultation and follow-up of CAPAs
  • Trial Master File Audits
  • Quality System Audits

IMP Management

  • QP audits of CMO according to EU GMP or 21 CFR
  • QP declarations for import into EU
  • QP certification of IMP for clinical trials